Emergence DeliriumPEDLA-QORNCT07604337
Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia
A study testing Pre-emptive Local Anesthesia and Articaine Hydrochloride With Epinephrine in people with Emergence Delirium and Pediatric Dental General Anesthesia, run by seher orbay yasli at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Emergence Delirium, Pediatric Dental General Anesthesia, Postoperative Recovery
- What is being tested?
- Pre-emptive Local Anesthesia and Articaine Hydrochloride With Epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 to 12 years
- ASA physical status I or II
- Scheduled for ambulatory dental treatment under general anesthesia
- Ability to understand and respond to age-appropriate pain and recovery assessment tools
- Written informed consent obtained from a parent or legal guardian
- Child assent obtained when appropriate
Who cannot join
- Known allergy or contraindication to local anesthetic agents
- Developmental delay or cognitive impairment preventing assessment
- Autism spectrum disorder or severe behavioral disorder
- Neurological disease affecting behavior or consciousness
- Chronic analgesic or sedative medication use
- Severe hepatic, renal, cardiac, or respiratory disease
Show all 9Show fewer
- Emergency dental procedure
- Need for postoperative hospital admission
- Inability to complete postoperative assessment tools
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry
Kayseri, Kayseri, 38039
SEHER Orbay Yaşlı, 05052401933, sehersin81@hotmail.com
About this study
Official title: Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial
This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.
Read the detailed description
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.
Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.
The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
- Being tested
- Pre-emptive Local Anesthesia, Articaine Hydrochloride With Epinephrine
- Keywords
- Pre-emptive local anesthesia, Pediatric anesthesia, Dental anesthesia, Emergence behavior, QoR-15 Pictorial, Ambulatory surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-emptive Local AnesthesiaProcedure or surgery
Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
Articaine Hydrochloride With EpinephrineDrug
Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Pre-emptive Local Anesthesia | Experimental | Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia. Receives: Procedure: Pre-emptive Local Anesthesia; Drug: Articaine Hydrochloride With Epinephrine |
| No Local Anesthesia | No intervention | Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia. Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale. The scale includes five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and consolability. Each item is scored from 0 to 4, with a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium symptoms. Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.
Measured: PACU minutes 0, 5, 10, 15, and 30
Secondary outcomes (2)
Postoperative Pain Score
Pain will be assessed using the Faces Pain Scale-Revised. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: PACU minutes 0, 5, 10, 15, and 30
Recovery Quality Before Discharge
Recovery quality will be assessed using the QoR-15 Pictorial form before discharge. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery quality.
Measured: Before discharge on day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either pre-emptive local anesthesia or no local anesthesia during ambulatory pediatric dental general anesthesia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- seher orbay yasli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, seher orbay yasli, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604337
- Sponsor's protocol ID
- PEDGA-LA-2026
- Acronym
- PEDLA-QOR
- Status last verified
- Jun 2026
- First submitted
- 14 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604337
- Acronym / sponsor ID
- PEDLA-QOR / PEDGA-LA-2026
- Keywords
- Pre-emptive local anesthesia, Pediatric anesthesia, Dental anesthesia, Emergence behavior, QoR-15 Pictorial, Ambulatory surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- seher orbay yasliUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate whether pre-emptive local anesthesia improves early recovery after ambulatory pediatric dental general anesthesia. Children aged 7-12 years scheduled for dental treatment under general anesthesia will be randomly assigned to receive either pre-emptive local anesthesia or no local anesthesia. Emergence delirium, pain, sedation level, and recovery quality will be assessed during the early postoperative period. The primary outcome will be the longitudinal Pediatric Anesthesia Emergence Delirium Scale score during the first 30 minutes in the post-anesthesia care unit.
Detailed description
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.
Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each emergence delirium and pain assessment. Emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium Scale at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.
The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves emergence delirium severity, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either pre-emptive local anesthesia or no local anesthesia during ambulatory pediatric dental general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Pre-emptive Local Anesthesia | Experimental | Procedure: Pre-emptive Local Anesthesia, Drug: Articaine Hydrochloride With EpinephrineChildren randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia. |
| No Local Anesthesia | No intervention | –Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia. Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7 to 12 years
- ASA physical status I or II
- Scheduled for ambulatory dental treatment under general anesthesia
- Ability to understand and respond to age-appropriate pain and recovery assessment tools
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (9 listed)
- Known allergy or contraindication to local anesthetic agents
- Developmental delay or cognitive impairment preventing assessment
- Autism spectrum disorder or severe behavioral disorder
- Neurological disease affecting behavior or consciousness
- Chronic analgesic or sedative medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-emptive Local AnesthesiaPre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded. | Procedure or surgery | Pre-emptive Local Anesthesia |
| Articaine Hydrochloride With EpinephrineArticaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group. The total volume, total dose, dose per kilogram, and injection sites will be recorded. | Drug | Pre-emptive Local Anesthesia |
Primary outcome
Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery
Time frame: PACU minutes 0, 5, 10, 15, and 30
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium Scale. The scale includes five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and consolability. Each item is scored from 0 to 4, with a total score ranging from 0 to 20. Higher scores indicate more severe emergence delirium symptoms. Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.
2 secondary outcomes
Postoperative Pain Score
Time frame: PACU minutes 0, 5, 10, 15, and 30
Recovery Quality Before Discharge
Time frame: Before discharge on day of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-emptive Local Anesthesia and Articaine Hydrochloride With Epinephrine in people with Emergence Delirium and Pediatric Dental General Anesthesia, run by seher orbay yasli at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Orbay Yaşlı, Assistant Professor of Anesthe (+905052401933, sehersin81@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium Scale Score During Early Recovery (time frame: PACU minutes 0, 5, 10, 15, and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.